WARNINGS AND PRECAUTIONS

Substantial Edits to Section 5.6 Metabolic Changes based upon two adequate and well-controlled trials that demonstrate the efficacy for the new indication in pediatric patients with Tourette’s Disorder.

WARNINGS AND PRECAUTIONS

Metabolic Changes

Atypical antipsychotic drugs have been associated with metabolic changes that include hyperglycemia/diabetes mellitus, dyslipidemia, and body weight gain. While all drugs in the class have been shown to produce some metabolic changes, each drug has its own specific risk profile…

Dyslipidemia: Undesirable alterations in lipids have been observed in patients treated with atypical antipsychotics. There were no significant differences between aripiprazole- and placebo-treated patients in the proportion with changes from normal to clinically significant levels for fasting/nonfasting total cholesterol, fasting triglycerides, fasting LDLs, and fasting/nonfasting HDLs. Analyses of patients with at least 12 or 24 weeks of exposure were limited by small numbers of patients…

Weight Gain:Weight gain has been observed with atypical antipsychotic use. Clinical monitoring of weight is recommended…